NCT00903136

Brief Summary

RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of the esophagus, stomach, and duodenum in screening for Barrett esophagus. PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in screening participants for Barrett esophagus.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

January 10, 2014

Status Verified

February 1, 2010

Enrollment Period

2.6 years

First QC Date

May 15, 2009

Last Update Submit

January 9, 2014

Conditions

Esophageal CancerPrecancerous Condition

Keywords

Barrett esophagusesophageal canceradenocarcinoma of the esophagus

Outcome Measures

Primary Outcomes (13)

  • Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)

  • Time required to image the squamo-columnar junction (Phase I)

  • Number of repeated swallows to achieve esophageal imaging (Phase I)

  • Amount of simethicone needed to reduce bubbles (Phase I)

  • Need for effervescent granules or other approaches to distend the esophagus (Phase I)

  • Time required for the entire TCE procedure (Phase I)

  • Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I)

  • Overall comfort during ingestion, pullback, and withdrawal of the TCE (Phase I)

  • Sensitivity, specificity, and accuracy of the TCE for identifying suspected Barrett esophagus (Phase II)

  • Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II)

  • Time to perform the TCE exam (Phase II)

  • Test characteristics of the first half vs the last half of the TCE exams performed by each of the 2 endoscopists (Phase II)

  • Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II)

Secondary Outcomes (2)

  • Ability of the TCE to identify the presence or absence of other esophageal lesions (e.g., inflammation, diverticula, or varices) (Phase II)

  • Results of the histologic analysis of any biopsy specimens (Phase II)

Interventions

questionnaire administrationOTHER
comparison of screening methodsPROCEDURE
diagnostic endoscopic procedurePROCEDURE
esophagogastroduodenoscopyPROCEDURE
tethered capsule endoscopyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Healthy participant (phase I) * Scheduled to undergo esophagogastroduodenoscopy at the VA Puget Sound Health Care System for the evaluation of reflux symptoms (including screening for Barrett esophagus \[BE\]) or for follow-up of known BE (phase II) * No current diagnosis of cancer PATIENT CHARACTERISTICS: * Not pregnant * Able to fast for ≥ 6 hours prior to scheduled appointment * No symptoms of dysphagia * No history of a swallowing disorder (e.g., scleroderma, achalasia, esophageal stricture, or esophageal diverticulum) * No history of a known or suspected gastrointestinal (GI) obstruction * No other major medical illnesses (e.g., unstable cardiovascular disease, end-stage liver or kidney disease, or suspected active GI bleeding) * No major physical disability that would prevent the participant from transferring from a chair to a bed and sitting up * Not planning to undergo an MRI within 2 weeks after the study procedure PRIOR CONCURRENT THERAPY: * No prior surgery on the oropharynx, neck, esophagus, or stomach * No concurrent anticoagulant medications or clopidogrel

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsPrecancerous ConditionsBarrett EsophagusAdenocarcinoma Of Esophagus

Interventions

Endoscopy, Digestive SystemEndoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Jason A. Dominitz, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
SCREENING
Sponsor Type
FED

Study Record Dates

First Submitted

May 15, 2009

First Posted

May 18, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2011

Last Updated

January 10, 2014

Record last verified: 2010-02

Locations

US(1)